How will informed consent and medical records release authorization be handled?
All Study protocols and consent materials have been reviewed by multiple Institutional Review Boards (IRBs) at the national and local levels. Each woman enrolling in the National Children’s Study will be informed about participation and asked to consent to it. Prior to her child’s birth, she will also be asked for permission for Study staff to obtain her medical information. This form will be HIPAA compliant, and a copy of the patient’s signed authorization form will be provided to the labor and delivery facility at, or prior to, birth. Study staff will request that participants sign additional authorization forms as facilities require. Assent will be sought from the children themselves as they get older, and when they reach the age of legal consent, they will be asked to provide informed consent. What safeguards are in place for the protection of each participants’ privacy? Confidentiality for all Study participants is critical for the Study to be successful. Privacy protection and co
All Study protocols and consent materials have been reviewed by multiple Institutional Review Boards (IRBs) at the national and local levels. Each woman enrolling in the National Children’s Study will be informed about participation and asked to consent to it. Prior to her child’s birth, she will also be asked for permission for Study staff to obtain her medical information. This form will be HIPAA compliant, and a copy of the patient’s signed authorization form will be provided to the labor and delivery facility at, or prior to, birth. Study staff will request that participants sign additional authorization forms as facilities require. Assent will be sought from the children themselves as they get older, and when they reach the age of legal consent, they will be asked to provide informed consent.
Related Questions
- When releasing the medical records of a patient, with a properly executed authorization, may we release records of other physicians or clinics which may have been sent to us?
- Do the core elements of an Authorization differ from a medical records release form?
- How will informed consent and medical records release authorization be handled?
